Senior Biostatistician: Shape Life-Changing Evidence

Edwards Lifesciences Gruppe

Irvine, Des Moines (CA, IA)

On-site

USD 119,000 - 168,000

Full time

9 days ago

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Job summary

Edwards Lifesciences in Irvine, CA seeks a Senior Biostatistician to support clinical studies from SAP development to statistical analyses and reporting. You will collaborate with clinicians, regulatory teams, and cross-functional partners to ensure robust statistical support across the study lifecycle.

The role requires a PhD or equivalent in Statistics/Biostatistics (or related) and experience with regulatory guidance (GCP/FDA).

Qualifications

Ph.D. or equivalent in Statistics, Biostatistics, or related field.
Master's Degree or equivalent in Statistics, Biostatistics or related field, 2 years analytical experience in clinical trials.
Knowledge of regulatory guidelines (GCP, FDA) and strong communication skills.

Responsibilities

Develop Statistical Analysis Plans (SAPs) and lead execution for assigned studies.
Develop statistical programs to ensure accuracy of analyses.
Review protocols and contribute to statistical sections; generate randomization schemes when appropriate.
Author results sections of clinical study reports and contribute to PMA submissions.
Provide independent validation of statistical content in study documents and other materials.
Interpret results and communicate findings to cross-functional stakeholders.
Keep abreast of new developments in statistics and regulatory guidance.
Represent Biostatistics on study teams and manage deliverables and timelines.
Participate in developing case report forms and data support data cleaning activities.